(136 days)
The Arm Blood Pressure Monitor is intended to measure the systolic blood pressure, as well as the pulse rate of adult person via non-invasive oscillometric technique in which an inflatable CUFF is wrapped around the upper arm at medical facilities or at home.
AOJ-30 series Arm blood pressure monitor is designed as a battery driven automatic non-invasive blood pressure monitor. It can automatically complete the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult person at upper arm within its claimed range and accuracy via the oscillometric technique. The result will be displayed in the international unit mmHg or kPa. The device has the data storage function in order for data reviewing, including the systolic pressure, diastolic pressure, pulse rate and measurement time. The device also has low voltage indication, which will be triggered when the battery is low. The proposed device is intended to be used in medical facilities or at home. And the effectiveness of this sphygmomanometer has not been established in pregnant (including pre-eclamptic) patients. The product is provided non-sterile, and not to be sterilized by the user prior to use. All the models included in this submission follow the similar software, same measurement principle and same specifications. The differences existed between different models included in this submission will not affect the safety and effectiveness of the device. AOJ-30A and AOJ-30B include the Bluetooth transmission functionality which can transfer data for Application in the external instruments, and the measuring data, including systolic diastolic pressures and pulse rate can be displayed, stored and reviewed by the Application in the external instruments without any control feature, therefore, no interoperability happened. This function is not available for other models.
The provided text describes the 510(k) submission for the Shenzhen AOJ Medical Technology Co., Ltd. Arm Blood Pressure Monitor (AOJ-30 series). This document focuses on demonstrating the substantial equivalence of the new device to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria in the context of an AI/ML study.
Therefore, many of the requested details, such as those related to AI/ML performance (e.g., sample size for training set, number of experts for ground truth, MRMC study, standalone performance), are not applicable to this document as it pertains to a traditional non-invasive blood pressure monitor.
However, I can extract information related to the performance testing and clinical validation for this type of medical device as presented in the document.
Study Details Proving Device Meets Acceptance Criteria (as per the provided document)
The document describes the performance testing undertaken to demonstrate substantial equivalence to a predicate device, focusing on accuracy, safety, and effectiveness for a non-invasive blood pressure monitor.
1. Table of Acceptance Criteria and Reported Device Performance
The core "acceptance criteria" for a non-invasive oscillometric sphygmomanometer like this are typically defined by international standards for accuracy. The document explicitly references these standards for performance effectiveness.
| Criterion | Acceptance Standard (as per referenced ISO 80601-2-30) | Reported Device Performance (as per comparison table) |
|---|---|---|
| Blood Pressure Measurement Accuracy | ± 3 mmHg (standard) | ± 3 mmHg |
| Heart Rate Measurement Accuracy | ± 5% of reading (standard) | ± 5% of reading |
| Biocompatibility | Meets ISO 10993-1, 5, 10 for Cytotoxicity, Skin Sensitization, Skin Irritation | Testing conducted per standards, passed |
| Electrical Safety | Meets IEC 60601-1, IEC 60601-1-11, ISO 80601-2-30 | Compliance stated |
| Electromagnetic Compatibility (EMC) | Meets IEC 60601-1-2 | Compliance stated |
| Software Verification & Validation Testing | Aligned with FDA Guidance for "Major" Level of Concern | Testing conducted, documentation provided |
Note: The performance values (± 3 mmHg for BP, ± 5% for HR) are commonly accepted accuracy requirements for non-invasive oscillometric blood pressure monitors as per standards like ISO 81060-2. The document states the device has this accuracy, implying it meets these criteria.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Clinical Validation: "100 subjects were involved for each study" (for the upgraded AOJ-30A, AOJ-30C, AOJ-30D, and AOJ-30E models).
- Data Provenance: Not explicitly stated regarding country of origin, but the submitting company is Shenzhen AOJ Medical Technology Co., Ltd. in China. The study is described as "clinical testing... conducted per IEC 81060-2: 2013." The nature of the study is prospective clinical validation as it describes involving subjects and conducting tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- The document implies ground truth (reference blood pressure measurements) would be established by experts as per the standard ISO 81060-2:2018. This standard typically requires a certain number of qualified observers (e.g., trained healthcare professionals) taking reference measurements. However, the exact number of experts and their specific qualifications are not explicitly detailed in this document. It only states: "Observer preparation, Reference determination, Clinical investigation methods and Data analysis are referred to ISO 81060-2: 2018 without any deviation."
4. Adjudication Method for the Test Set
- The document refers to ISO 81060-2:2018 for "Reference determination" and "Clinical investigation methods." This standard outlines specific methodologies for obtaining simultaneous reference blood pressure measurements (e.g., using a mercury sphygmomanometer or an automated reference device), which inherently involves a form of "ground truth" or reference standard, but it's not an "adjudication method" in the sense of multiple independent readers evaluating images, as would be the case for an AI/ML study.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/ML devices where human readers' performance with and without AI assistance is evaluated. This document concerns a standalone blood pressure monitor.
6. If a Standalone (i.e. Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Yes, the core of the clinical validation described is a standalone performance test of the device's measurement accuracy against a reference standard. The device itself is an automated blood pressure monitor without human interpretation requirements beyond reading the displayed values. The accuracy values (± 3 mmHg for BP, ± 5% for HR) are standalone performance metrics.
7. The Type of Ground Truth Used
- The ground truth for the clinical validation of blood pressure devices is established through simultaneous, direct measurements by a highly accurate reference method (e.g., auscultatory method with trained observers using a mercury sphygmomanometer, or another validated reference device) conducted according to the specified international standard (ISO 81060-2:2018). This is implied by the statement "Reference determination... referred to ISO 81060-2: 2018 without any deviation." It's essentially "expert consensus" in the sense of adhering to a standardized clinical protocol for reference measurements.
8. The Sample Size for the Training Set
- Not applicable. This document describes the validation of a hardware-based blood pressure monitor (oscillometric technique), not an AI/ML device that requires a "training set" in the machine learning sense. The device's algorithm for blood pressure determination is pre-सेट and does not undergo "training" on a dataset in the way an AI model would.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As above, there is no "training set" for this type of device.
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).